Connection apparatus for a medical device

ABSTRACT

A connection apparatus for a medical device includes a first connection member having a first end and a second end with the first connection member defining at least one channel adjacent the first end. The at least one channel having a first portion extending in an axial direction and a shoulder adjacent to the first end of the first connection member that defines a channel entry. The at least one channel having a second portion extending in a transverse direction relative to the axial direction. The connection apparatus further including a second connection member having a first end and a second end and at least one protrusion adjacent the first end. The shoulder is configured to guide the at least one protrusion of the second connection member into the channel entry regardless of the orientation of the at least one protrusion relative to the channel entry.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/532,177, filed Nov. 4, 2014, which claims priority to U.S.Provisional Application Ser. No. 61/900,661, filed Nov. 6, 2013, each ofwhich are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present application relates to a connection apparatus for a medicaldevice. More specifically, the present application relates to connectionmembers for closed system transfer devices (CSTDs), including connectionmembers that can mate and lock together two connection members of aCSTD.

Description of Related Art

The treatment of many conditions, disorders, and diseases involves theadministration of toxic compounds. For example, treatment of certainkidney disorders often involves administration of cyclophosphamide, analkylating agent. While the side-effects of cyclophosphamide treatmentare well known and expected in patients who receive this treatment,healthcare practitioners who administer cyclophosphamide also face arisk of exposure during reconstitution of the drug and subsequentadministration to the patient.

Devices for reconstitution and subsequent administration of toxiccompounds, known as closed system transfer devices (CSTDs), are known inthe art. Generally, these devices include an adapter for connection to avial containing the powdered or lyophilized compound, an adapter on asyringe, and an adapter on a conduit providing fluid access to thepatient's circulatory system. Typically, the healthcare practitionerwill reconstitute the powdered or lyophilized compound with saline orsome other reconstitution medium by attaching the syringe to the vialvia connection of the respective adapters, reconstitute the drug,aspirate the compound into the syringe, disconnect the adapters, andthen attach the syringe to the fluid conduit through the respectiveadapters for administration to the patient.

Inherent in the typical CSTD is the need to connect and disconnect thevarious adapters in order to reconstitute and administer the drug. Suchrepeated connection and disconnection increases the risk of accidentsand exposure to the toxic compounds. The issue of safety inadministration of these compounds is one that has been identified asbeing of critical importance by professional organizations andgovernment agencies alike.

SUMMARY OF THE INVENTION

In one aspect, a connection apparatus for a medical device includes afirst connection member having a first end and a second end with thefirst connection member defining at least one channel adjacent the firstend. The at least one channel has a first portion extending in an axialdirection and a shoulder adjacent to the first end of the firstconnection member that defines a channel entry. The at least one channelhaving a second portion extending in a transverse direction relative tothe axial direction. The connection apparatus also includes a secondconnection member having a first end and a second end with the secondconnection member having at least one protrusion adjacent the first end.When the at least one protrusion of the second connection member entersthe at least one channel of the first connection member, axial movementof the second connection member towards the first connection membercauses at least one of the first and second connection members to rotaterelative to the other connection member to enter a locked state, whereinthe shoulder is configured to guide the at least one protrusion of thesecond connection member into the channel entry regardless of theorientation of the at least one protrusion relative to the channelentry.

The channel entry may be wider than the first portion of the at leastone channel and the second portion of the at least one channel. Thesecond portion of the at least one channel may include a notch extendingin the axial direction. The notch may extend towards the first end ofthe first connection member. In other aspects, the notch may extendtowards the second end of the first connection member relative to thesecond portion of the at least one channel. The at least one protrusionmay form a positive lock with the notch to removably secure the firstconnection member to the second connection member when the first andsecond connection members are in the locked state. The second portion ofthe at least one channel may be a substantially axial notch extendingdistally and a substantially axial notch extending proximally relativeto the first end of the first connection member.

The first and second connection members may include fluid channelstherethrough such that when the first connection member and secondconnection member are mated, the fluid channels form a fluid path. Atleast one of the first connection member and second connection membermay include a self-healing membrane in the respective fluid channel andwith the first connection member mated with the second connectionmember, the self-healing membrane forms a fluid-tight seal. Theconnection apparatus may include an indicator of the locked statebetween the first connection member and the second connection member.The indicator may be a visual indicator. In one aspect, the first andsecond connection members may each include a flat portion and a roundedportion, with the visual indicator formed by alignment of the flatportion of the first connection member with the flat portion of thesecond connection member and the alignment of the round portion of thefirst connection member with the round portion of the second connectionmember. In other aspects, the indicator may be a tactile indicator, suchas the interaction of the at least one protrusion with a notch providingtactile indication of the locked state.

The first end of the second connection member may include sidewallsenclosing a hollow portion, where the sidewalls extend axially away fromthe second end of the second connection member, the sidewalls includethe at least one protrusion, and the at least one protrusion extendsinward. One of the first connection member and second connection membermay be provided on a syringe adapter with the other connection memberprovided on at least one of a vial adapter and a patient connector. Theshoulder may be rounded and the first portion of the at least onechannel may define a non-linear path.

In another aspect, a connection apparatus for a medical device includesa first connection member having a first end and a second end, with thefirst connection member defining at least one channel adjacent the firstend. The at least one channel having a first portion extending from aposition adjacent the first end of the first connection member towardthe second end of the first connection member. The at least one channelhaving a shoulder adjacent to the first end of the first connectionmember that defines a channel entry and a second portion extending fromthe first portion. The connection apparatus also includes a secondconnection member having a first end and a second end with the secondconnection member having at least one protrusion adjacent the first end.The at least one protrusion of the second connection member isconfigured to be received by the at least one channel of the firstconnection member. The first connection member and the second connectionmember have a locked state where the first connection member is securedto the second connection member. The at least one protrusion of thesecond connection member is positioned in the second portion of the atleast one channel of the first connection member when the first andsecond connection members are in the locked state. The channel entry iswider than the first portion of the at least one channel of the firstconnection member.

The first portion of the at least one channel of the first connectionmember may be non-linear. The second portion of the at least one channelof the first connection member may extend in a transverse directionrelative to a longitudinal axis of the first connection member. Thesecond portion of the at least one channel may include a notch extendingin an axial direction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of a system for the closed transfer of fluidsaccording to one aspect of the present invention, showing a syringeadapter, a vial adapter, and a patient connector.

FIG. 2 is a front view of the patient connector of FIG. 1 according toone aspect of the present invention.

FIG. 3 is a side view of the patient connector of FIG. 1 according toone aspect of the present invention.

FIG. 4 is a bottom perspective view of the patient connector of FIG. 1according to one aspect of the present invention.

FIG. 5 is a top perspective view of the patient connector of FIG. 1according to one aspect of the present invention.

FIG. 6 is a cross-sectional view of the patient connector of FIG. 1according to one aspect of the present invention.

FIG. 7A is a front view of a connection member of the patient connectorof FIG. 1 according to a further aspect of the present invention.

FIG. 7B is a front view of a connection member of the patient connectorof FIG. 1 according to another aspect of the present invention.

FIG. 8 is a front view of the syringe adapter of FIG. 1 according to oneaspect of the present invention.

FIG. 9 is a side view of the syringe adapter of FIG. 1 according to oneaspect of the present invention.

FIG. 10 is a top perspective view of the syringe adapter of FIG. 1according to one aspect of the present invention.

FIG. 11 is a bottom perspective view of the syringe adapter of FIG. 1according to one aspect of the present invention.

FIG. 12 is a cross-sectional view of the connection member of thesyringe adapter of FIG. 1 according to one aspect of the presentinvention.

FIG. 13 is a front view of the vial adapter of FIG. 1 according to oneaspect of the present invention.

FIG. 14 is a side view of the vial adapter of FIG. 1 according to oneaspect of the present invention.

FIG. 15 is a bottom perspective view of the vial adapter of FIG. 1according to one aspect of the present invention.

FIG. 16 is a top perspective view of the vial adapter of FIG. 1according to one aspect of the present invention.

FIG. 17 is a cross-sectional view of the vial adapter of FIG. 1according to one aspect of the present invention.

FIG. 18 is a perspective view of the syringe adapter and the patientconnector of FIG. 1 in the process of being connected according to oneaspect of the present invention.

FIG. 19 is a perspective view of the syringe adapter and the patientconnector of FIG. 1 in a connected state according to one aspect of thepresent invention.

FIG. 20 is a cross-sectional view of the syringe adapter and the patientconnector of FIG. 1 in a connected state according to one aspect of thepresent invention.

FIG. 21 is a front view of the syringe adapter and the vial adapter ofFIG. 1 in a connected state according to one aspect of the presentinvention.

FIG. 22 is a perspective view of a vial adapter according to a secondaspect of the present invention.

FIG. 23 is a front view of a syringe adapter according to a secondaspect of the present invention, showing the syringe adapter connectedto the vial adapter of FIG. 22.

FIG. 24 is a bottom perspective view of the syringe adapter of FIG. 22and the vial adapter of FIG. 22, showing the syringe adapter connectedto the vial adapter.

FIG. 25 is a cross-sectional view of the syringe adapter of FIG. 22 andthe vial adapter of FIG. 22, showing the syringe adapter connected tothe vial adapter.

FIG. 26A is a partial front cutaway view of an alternative aspect of aprotrusion of a second connection member.

FIG. 26B is a partial front cutaway view of an alternative aspect of aprotrusion of a second connection member.

FIG. 26C is a partial front cutaway view of an alternative aspect of aprotrusion of a second connection member.

FIG. 26D is a partial front cutaway view of an alternative aspect of aprotrusion of a second connection member.

FIG. 26E is a partial front cutaway view of an alternative aspect of aprotrusion of a second connection member.

DESCRIPTION OF THE INVENTION

For purposes of the description hereinafter, the words “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and like spatial terms, if used, shall relate to thedescribed aspects as oriented in the drawing figures. However, it is tobe understood that many alternative variations and aspects may beassumed except where expressly specified to the contrary. It is also tobe understood that the specific devices and aspects illustrated in theaccompanying drawings and described herein are simply exemplary aspectsof the invention.

Referring to FIG. 1, one non-limiting aspect of system 1 for the closedtransfer of fluids between a first container and a second container (notshown) includes a syringe adapter 2, a vial adapter 4, and a patientconnector 6. The vial adapter 4 and the patient connector 6 include afirst connection member 10 and the syringe adapter 2 includes a secondconnection member 70. Although FIG. 1 shows the first connection member10 provided with the vial adapter 4 and the patient connector 6 and thesecond connection member 70 provided with the syringe adapter 2, thoseof skill in the art will understand and appreciate that the firstconnection member 10 and the second connection member 70 mayindependently be associated with any medical device. Further, the firstconnection member 10 may be associated with the syringe adapter 2 andthe second connection member 70 may be associated with the vial adapter4 and patient connector 6. Further, although not shown, the firstconnection member 10 may also be provided on an IV bag adapter or anyother device typically utilized in CSTD systems. Thus the aspectsillustrated in the accompanying figures should be considered merely,exemplary, non-limiting aspects.

Referring to FIGS. 1-7B and 13-17, the first connection member 10according to one non-limiting aspect of the present invention includes afirst end 20 and a second end 25. The first end 20 may be a solidstructure, and the second end 25 may be any type of structure, forexample and without limitation the second end 25 may be a grippingsurface, an adapter for use with a CSTD, a visual indicator fordetermining proper engagement of the connection member with anotherconnection member or other portion of the CSTD, or any usefulcombination thereof. First connection member 10 may be formed of anysuitable material, such as, without limitation, plastics andmedical-grade polymers. Such polymers are available from DuPont underthe trade names Crastin®, Delrin®, Hytrel®, and Zytel®. In non-limitingaspects in which second end 25 is a specific type of adapter, firstconnection member 10 may be formed of multiple suitable materials, withfirst end 20 formed of a plastic or medical-grade polymer, or anysuitable material.

With further reference to FIGS. 1-7B and 13-17, in a non-limiting aspectof the present invention, the first connection member 10 defines atleast one channel 30 that extends from a portion of the first end 20distal from the second end 25 to a portion of the first end 20 proximalthe second end 25. The channel 30 is utilized in the process of matingthe first connection member 10 and the second connection member 70(shown in FIGS. 8-12), and may follow any useful path. In non-limitingaspects, the channel 30 follows a non-linear path, such as asubstantially curved path as illustrated in FIGS. 1-7B and 13-17,although the channel 30 may also have a linear path or a path formed bya plurality of linear portion.

The channel 30 may have several discrete portions, including a channelentry 50, an axial or substantially axial portion 35 extending along thelength of the first end 20 of first connection member 10, and atransverse portion 60 proximal to the second end 25 that extendstransversely relative to the axial portion 35. First end 20 of firstconnection member 10, which includes channel entry 50, further includesa shoulder 40 defining the channel entry 50. In non-limiting aspects,shoulder 40 is rounded such that objects that contact the shoulder 40are guided into the channel entry 50. The rounded nature of the shoulder40 also permits mating of the first connection member 10 with the secondconnection member 70 (FIGS. 8-12) without the need for the members to bein any predetermined orientation, increasing the ease of achievingsecure connections. Rather than providing a rounded shoulder 40, theshoulder 40 may also come to a pointed peak or have any other suitableshape to guide the second connection member 70 into the channel entry 50regardless of the orientation of the mating components relative to eachother.

In non-limiting aspects, the transverse portion 60 of channel 30 issubstantially perpendicular to the axial portion 35 of channel 30. Innon-limiting aspects, the channel entry 50 is advantageously wider thanthe remaining portions 35, 60 of the channel 30, to increase ease ofmating first connection member 10 with second connection member 70,which will be described. In non-limiting aspects, the channel 30includes at a terminus of the transverse portion 60 at least one notch100. In certain non-limiting aspects, the notch 100 extends axially,either distally away from the second end 25 of the first connectionmember 10 or proximally, towards the second end 25 of the firstconnection member 10.

In non-limiting aspects as illustrated in FIG. 7A, at the terminus oftransverse portion 60 of channel 30, a plurality of notches is provided.In non-limiting aspects, a notch 110 extends distally away from secondend of the connection member and a notch 120 extends proximally towardsthe second end of the connection member. In such a configuration, agreater number of arrangements for securing protrusion 90 of a secondconnection member, and thus for securing first connection member andsecond connection member in a mated configuration, are possible. Thoseof skill in the art will understand and appreciate the wide variety ofmechanisms, such as springs and other compliant and elastic devices andapparatuses, which are useful for maintaining protrusion 90 withinnotches 110, and/or 120. The notches 110, 120 define bumps or structurethat may provide a tactile and auditory indication that the device is ina locked state. The protrusion 90 may only be maintained in the lockedposition through the engagement of the protrusion 90 with the structurethat defines the notches 110, 120 and may not be utilized in connectionwith a biasing member. In particular, the protrusion 90 and notches 110,120 may be configured to maintain a locked position within thetransverse portion 60 until a sufficient torque is applied to push theprotrusion 90 past the notches 110, 120.

In non-limiting aspects as illustrated in FIG. 7B, at the terminus oftransverse portion 60 of channel 30, a single notch is provided. Innon-limiting aspects, a notch 110 extends distally away from second endof the connection member. As noted above, the notch 110 may form a bumpand provide a tactile and auditory indication that the device is in alocked state. The protrusion 90 may only be maintained in the lockedposition through the engagement of the protrusion 90 with the structurethat defines the notch 110 and may not be utilized in connection with abiasing member. In particular, the protrusion 90 and notch 110 may beconfigured to maintain a locked position within the transverse portion60 until a sufficient torque is applied to push the protrusion 90 pastthe notch 110.

With reference to FIGS. 2-6, the first connection member 10 is shown inconnection with the patient connector 6. The patient connector 6 definesa fluid channel 130 that extends through the patient connector 6. Secondend 25 further includes surface 26 that allows for fitted mating withsecond connection member 70. Said surface 26 may be flat or any otherconfiguration that allows for close mating of first and secondconnection members 10, 70. Surface 26 of first connection member 10 mayalso include elastic or compliant means so that first 10 and second 70connection members can be urged together during mating and unmating. Thepatient connector 6 also includes a male or female threaded luer lock122 for connecting the patient connector 6 to a fluid conduit that is influid connection with a patient's circulation, such as an intravenouspatient line.

With reference to FIG. 6, the fluid channel 130 passes through thepatient connector 6 and the first connection member 10 and is configuredto be in fluid communication with a corresponding fluid channel of asecond connection member 70 such that when the first and secondconnection members 10, 70 are mated, a fluid path is formedtherethrough. Fluid channel 130 and/or first end 20 and second end 25 offirst connection member 10 may include seals or membranes in anyadvantageous location to aid in the formation of a fluid-tight seal whenfirst connection member 10 is mated to second connection member 70. Suchseals and membranes are known to those of skill in the art, and mayinclude self-healing seals and membranes and should be selected based onthe intended use for the device such as biocompatibility, chemicallyinert, and compatible with any chemical reagents or treatments containedtherein, be FDA and/or OSHA approved, and suitable for use in CSTDs.Such seals may be formed out of natural materials such as rubber,synthetic polymers, and/or silicone, such as room temperaturevulcanizing silicone. In particular, the proximal end of the first end20 of the connector may include a membrane that mates a forms a sealwith a corresponding member of the second connection member 70.

Referring to FIGS. 8-12, the syringe adapter 2 includes the secondconnection member 70, which is configured to mate with first connectionmember 10. Second connection member 70 includes first end 80 and secondend 85. Second connection member 70 may be formed out of any suitablematerial. For example, and without limitation, second connection member70 may be formed out of plastic or a medical-grade polymer. Innon-limiting aspects, second connection member 70 is formed from thesame material as first connection member 10 or first end 20 of firstconnection member 10. First end 80 further includes surface 81 thatallows for fitted mating with surface 26 of first connection member 10.Said surface 81 may be flat or any other configuration that allows forclosed mating of first and second connection members 10, 70 throughinteraction of surfaces 26 and 81. Surface 81 of second connectionmember 70 may also include elastic or compliant structure so that first10 and second 70 connection members can be urged together during matingand unmating. In non-limiting aspects, second connection member 70 mayinclude a male or female threaded luer lock 121.

Referring to FIG. 12, syringe adapter 2 defines fluid channel 140 thatpasses through first end 80 and second end 85. The syringe adapter 2allows for connection (through luer lock 121) to a syringe to, forexample and without limitation, reconstitute a drug, or aspirate a drugfrom a vial (through interaction with a vial adapter having a connectionmember). Although a luer lock 121 is shown, any other suitableconnection may be utilized. Aspirated drugs can be provided to a patientthrough interaction with the patient connector 6 having the firstconnection member 10. First end 80 of the second connection member 70has sidewalls 160 that define an interior cavity 170 including at leastone protrusion 90. Protrusion 90 is dimensioned to interact with channel30 of first connection member 10. Specifically, in a non-limitingaspect, when first connection member 10 is mated with second connectionmember 70 by engaging first end 20 of first connection member 10 withfirst end 80 of second connection member 70, first end 20 of firstconnection member 10 engages the first end 80 of second connectionmember 70.

Referencing FIGS. 2-5 and 11, if protrusion 90 is aligned with channelentry 50, second connection member 70 will engage with first connectionmember 10. However, if protrusion 90 is not aligned with channel entry50, protrusion 90 may contact shoulder 40. In certain aspects, whereshoulder 40 is advantageously rounded or sloped, protrusion 90 is guidedinto channel entry 50 by the shape of the shoulder, allowing for matingof first connection member 10 and second connection member 70. Therounded nature of the shoulder 40 permits mating of the first connectionmember 10 with a second connection member 70 without the need for themembers to be in any predetermined orientation, increasing the ease ofachieving secure connections. Those of skill in the art will understandthat the above-described principle, and mating process, will likewisefunction if first connection member 10 has a protrusion extendingradially outward and second connection member 70 has a channel on aninterior surface. Thus, the illustrations in the accompanying drawingsand described herein should be considered exemplary aspects of theinvention.

With continuing reference to FIGS. 2-5 and 11, when protrusion 90 isaligned with channel entry 50, protrusion 90 can enter channel 30 andallow for engagement of first connection member 10 and second connectionmember 70. As first connection member 10 and second connection member 70come into further engagement, protrusion 90 proceeds further alongchannel 30, proceeding through axial portion 35. In non-limiting aspectsin which channel 30 is non-linear, passage of protrusion 90 along a paththat may be, for example and without limitation, curved, rotates one orboth of the connection members 10, 70 relative to the other connectionmember, or relative to each other.

The non-linear, or curved, path of the channel 30 brings protrusion 90to the transverse portion 60 of the path 30 with rotation of the firstand/or second connection members 10, 70. Continued rotation of the firstconnection member 10 and/or second connection member 70 moves protrusion90 along transverse portion 60 of path 30, and protrusion 90 approachesnotch 100. As first connection member 10 and/or second connection member70 rotate further, protrusion 90 reaches the terminus of the path 30,and further rotation is not possible. Release of first connection member10 and/or second connection member 70 allows protrusion 90 to enternotch 100. This entry prevents disengagement of the mated firstconnection member 10 and second connection member 70. Protrusion 90remains engaged with notch 100 through any suitable arrangement, forexample and without limitation through use of compliant structure suchas, for example and without limitation, compression coil/helical springsand tension coil/helical springs. Those of skill in the art are aware ofthe types of devices that can provide sufficient force or tension tomaintain protrusion 90 in notch 100, and thus maintain engagement of theconnection members. As noted in connection with the aspects shown inFIGS. 7A and 7B, the notches 110, 120 define bumps or structure thatcreate an interference fit between the protrusion 90 and the firstconnection member 10 such that, once the protrusion 90 is forced pastthe bump or bumps, the first connection member 10 will remain connectedto the second connection member 70 unless a predetermined amount oftorque is applied to the member 10, 70 to force the protrusion 90 pastthe bump(s) again and back through the path 30. Accordingly, theprotrusion 90 of the second connection member 70 has a clearance fitwhen moving into notch 100 of the first connection member 10 shown inFIG. 2 and require a biasing force to maintain the protrusion 90 withinthe notch 100 whereas the notches 110, 120 of the first connectionmember 10 shown in FIGS. 7A and 7B may define a friction engagement withthe protrusion 90 such that the biasing force is unnecessary to maintainthe locked engagement. However, the notch 100 shown in FIG. 2 and thenotches 110, 120 of FIGS. 7A and 7B may each be utilized in a clearanceor friction fit engagement with the protrusion 90 and with or without abiasing force to maintain a secure connection.

In certain non-limiting aspects, first end 20 of first connection member10 is a solid cylinder and first end 80 of second connection member 70defines a hollow cylindrical body with the protrusion 90 facing inwardinto the hollow portion. Mating of the two connection members 10, 70 isaccomplished by inserting first end 20 of first connection member 10into the hollow body of first end 80 of second connection member 70 or,alternatively, sliding the hollow body of first end 80 of secondconnection member 70 over first end 20 of first connection member 10.Those of skill in the art will appreciate that in additional aspectswithin the scope of the present invention, the protrusion may be presenton first connection member 10 and face outward, with second connectionmember 70 having a channel for receiving said protrusion and a notch forforming a positive lock with said protrusion.

Referring again to FIG. 12, the second connection member 70 includes aseal or membrane apparatus 150. Seal or membrane apparatus 150 isconfigured to mate with a corresponding seal on the second connectionmember 10 to form a sealed interface between the first and secondconnection members 10, 70 during the transfer of fluids. Seal ormembrane apparatus 150 may also be a part of first connection member 10.

In non-limiting aspects, seal or membrane apparatus 150 may beself-healing and may also be a multi-component seal or membrane. Forexample, in the aspect illustrated in FIG. 12, seal apparatus 150includes a first seal 151, a seal carrier 152, and a second membrane153. The seal carrier 152 receives the first seal 151 at one end and thesecond seal 153 at the opposite end. The first and second seals 151, 153define a space 154 therebetween. The second connection member alsoincludes a needle 155 in fluid communication with the fluid channel 140and a biasing member 157, such as a spring, positioned between the luerlock 121 and the seal apparatus 150. The seal apparatus 150 isconfigured to move within the housing between a shielded and unshieldedposition. As discussed below, when the second connection member 70 ismated with the first connection member 10, the seal apparatus 150 ismoved upwardly within the second connection member 70 thereby storingenergy within the biasing member 157, i.e., compressing the biasingmember. When the seal apparatus 150 is moved within the secondconnection member 70, the needle 155 pierces the seal 153 and places thefirst connection member 10 in fluid communication with the secondconnection member 70 to transfer fluid between a first container, suchas a syringe, and a second container, such as a vial, IV bag, or patientIV line. During connection of the second connection member 70 with thefirst connection member 10, the seal 153 may engage and form a sealedmember with a corresponding seal member provided on the first connectionmember to prevent the leakage of any fluid during the transfer of fluidthrough the first and second connection members 10, 70. In anunconnected state of the second connection member 70, the distal tip ofthe needle 155 is positioned in the space 154 between the first andsecond seals 151, 153 to contain the distal tip of the needle 155 withinthe carrier 152. Alternative arrangements for the seal or membraneapparatus 150 may be utilized in connection with the first and secondconnection members 10, 70.

Seals or membranes suitable for use with the present invention in theaspect shown in FIG. 12 and described above, or with a singularself-healing seal or membrane, are well-known to those in the art andallow penetration by a point, i.e., needle, such that upon withdrawal ofthe point, the seal substantially reseals to preclude fluid passage.Suitable materials for the seals are well known in the art and should beselected based on the intended use for the device such asbiocompatibility, chemically inert, and compatible with any chemicalreagents or treatments contained therein, be FDA and/or OSHA approved,and suitable for use in CSTDs. Such seals may be formed out of naturalmaterials such as rubber, synthetic polymers, and/or silicone, such asroom temperature vulcanizing silicone.

In any aspect of the present invention, additional fluid-tight seals ormembranes may be provided at any advantageous location to increasesafety for the user. For example, and without limitation, materialssuitable for forming fluid-tight seals may also be provided on thesurface 26 of second end 25 of first connection member 10 that contactssurface 81 of first end 80 of second connection member 70 and/or on thesurface 81 of the first end 80 of the second connection member 70 thatcontacts surface 26 the second end 25 of the first connection member 10.As noted above, the proximal end of the first end 30 of the firstconnection member 10 may be provided with a seal that is configured toengage the seal 153 of the second connection member 70 such that whenthe first connection member 10 and the second connection member 70 aremated, a fluid-tight seal is formed therebetween and any possibleleakage from an accident can be contained in the fluid path formed byfluid channels 130 and 140.

The interaction of the protrusion 90 of the second connection member 70with the channel 30 and, ultimately, the notch 100, 110, and/or 120 ofthe first connection member 10 forms a positive lock, and secures thefirst connection member 10 with the second connection member 70. Becauseprotrusion 90 remains engaged with notch 100 through any suitable means,for example and without limitation through use of biasing member 157(referencing FIG. 12) such as, for example, and without limitation,compression coil/helical springs and tension coil/helical springs, anadditional force apart from mere rotation is required to break thepositive lock. The additional force required to break the positive lockmay be urging the first connection member 10 and/or second connectionmember 70 towards each other, or pulling the same away from each other.Accordingly, in one aspect, the force of the biasing member 157 must beovercome to disconnect the first connection member 10 from the secondconnection member 70. In other words, the biasing force of the biasingmember 157 maintains the first and second connection member 10, 70 in alocked, connected position by biasing the protrusion 90 within the notch100. When the force of the biasing member 157 is overcome, the secondconnection member 70 may be rotated and removed from the firstconnection member 10. As noted above, when the first connection member10 is disconnected from the second connection member 70, the biasingmember 157 transitions the seal carrier 152 back to the position shownin FIG. 12 with the distal end of the needle 155 positioned within thespace 154. With respect to the aspects shown in FIGS. 7A and 7B, thebump(s) defined by the notches 110, 120 create an interference fitbetween the protrusion 90 and the first connection member 10 such that,once the protrusion 90 is forced past the bump or bumps, the firstconnection member 10 will remain connected to the second connectionmember 70 unless a predetermined amount of torque is applied to themembers 10, 70 to force the protrusion 90 past the bump(s) again andback through the path 30. Accordingly, in connection with the aspects ofFIGS. 7A and 7B, the biasing member 157 is not necessarily needed tocreate a positive lock between the members 10, 70 such that the membersdo not need to be axially moved relative to each other to overcome thepositive lock.

Turning to FIGS. 13-17, as indicated elsewhere, connection members 10and 70 can be utilized in connection with any suitable medical deviceand in particular, CSTDs. In certain non-limiting aspects, theconnection apparatus may be utilized with structures or devices for usein CSTD systems, such as the patient connector 6 shown in FIGS. 2-6 andthe syringe adapter 2 shown in FIGS. 8-12. The connection apparatus mayalso be provided in connection with vial adapters (as shown in FIGS.13-17), for forming a connection with a vial containing, for example andwithout limitation, a lyophilized compound. The vial adapter 4 may allowfor formation of a fluid and air-tight seal to prevent exposure to thecompound, which may be toxic. The additional structures may also includesyringe adapters, to allow for reconstitution of compounds and transferof reconstituted compound, and/or patient connectors, to allow forintroduction of the compound to the patient's circulatory system by wayof an intravenous access.

With reference to FIG. 13, a non-limiting aspect of the first connectionmember 10 of the connection apparatus is provided in connection with thevial adapter 4. First connection member 10 includes first end 20 andsecond end 25. First end 20 includes a guide channel 30 having an axialportion 35 and a transverse portion 60. Transverse portion 60 of channel30 has a terminus at which a notch 100 is located. Those of skill willappreciate that any type of notch, for example those denoted 110 and/or120 in FIGS. 7A and 7B may be utilized within the scope of thisinvention. Channel 30 further includes channel opening 50 defined atleast in part by shoulder 40, which may be rounded in non-limitingaspects. Second end 25 of first connection member 10 may further includea vial attachment 190. This vial attachment allows for connection to avial containing a lyophilized compound, though compounds in a liquidstate may also be in such a vial when the liquid compound requires safeand secure transfer to a syringe and/or a patient.

In further non-limiting aspects, the vial adapter 4 may include furtherstructures or features that add additional safety and security to thereconstitution and/or withdrawal of a compound from a vial. For example,and without limitation, the vial attachment 190 may include arms 191 forattachment to a vial (not shown). Arms 191 may include protrusions 192that are angled to allow for ease of attachment to a vial. For example,in the aspect shown in FIGS. 13-17, angled portions 192 of arms 191allow for a vial to be attached to vial attachment 190 by forcing vialinto space between arms 191, or by forcing vial attachment 190 onto avial such that the arms 191 encircle the neck of the vial. In certainnon-limiting aspects, surfaces 193 can engage with a vial and lock thevial into place, preventing accidental separation of vial and vialattachment 190. In non-limiting aspects, upon mating of the vial withthe vial attachment 190, spike 195 pierces the vial. Although not shown,a seal or membrane may be positioned at the proximal end of the firstend 20 of the first connector 10 such that it is configured to mate withthe seal 153 of the syringe adapter 2.

In further non-limiting aspects, and as shown in FIGS. 13-17, the vialadapter 4 may further include a pressure equalization member 200. Thepressure equalization member 200 is shown schematically and may be aballoon-type arrangement, bellows-type arrangement, or any other type ofpressure equalization device known to those of skill in the art. Suchpressure equalization members reduce the likelihood of exposure byreducing the risk of release of toxic or harmful substances throughalteration or differences in pressures between the syringe and vial, orbetween vial and atmosphere by maintaining a neutral pressure duringinjection into or aspiration from a vial, thus reducing the risk ofsprayback.

With reference to FIG. 17, the vial adapter 4 defines a fluid channel130 that is configured to be in fluid communication with the interior ofa vial (not shown). The vial adapter 4 further defines a vent channel131 to allow for communication between a vial and the pressureequalization member 200. The vent channel 131 allows the pressureequalization member 200 to equalize the pressure within the vial duringmating, reconstitution, and aspiration, and reduces the risk ofsprayback.

With reference to FIGS. 1-6 and 8-19, in certain non-limiting aspects,the system 1 includes one or more indicators that provide an indicationthat the first connection member 10 and second connection member 70 arein a locked state, i.e., that the protrusion 90 and notch 100, 110,and/or 120 have formed a positive lock. The indicator may be any type ofuseful indicator, for example it may provide indication of a lockedstate by visual, tactile, or auditory means, or by any combination ofsuch means. For example, and without limitation, the movement of theprotrusion 90 into notch 100, 110, and/or 120 may provide an auditoryand/or tactile indication of the formation of a positive lock, by, forexample, a click or other familiar noise, and/or movement of theprotrusion 90 into a positive lock with notch 100, 110, and/or 120.

In other non-limiting aspects, the indicator may be visual alone, orvisual in connection with tactile or auditory. For example, and withoutlimitation, a possible indicator is shown in the prior figures, but isspecifically referenced in FIG. 19 and shows a visual indicator 165 thatcomprises the second end 25 of first connection member 10 and first end80 of second connection member 70. The indicator 165 is such that whenthe first connection member 10 and second connection member 70 are in alocked stated because of interaction of protrusion 90 and notch 100,110, and/or 120, and interaction of surface 26 of first connectionmember 10 and surface 81 of second connection member 70, the geometry ofthe exterior of second end 25 of first connection member 10 and thefirst end 80 of second connection member 70 form a visual indication ofthat locked state. The visual indication may be a formation of aparticular geometry and/or alignment of one or more visual indicatorspresent on the second end 25 of first connection member 10 and the firstend 80 of second connection member 70.

For example and without limitation, and with continuing reference toFIG. 19, indicator 165 can include a general geometric shape formed bythe second end 25 of first connection member 10 and the first end 80 ofsecond connection member 70. The presence of a locked state betweenfirst connection member 10 and second connection member 70 is indicatedby a uniform geometry of the visual indicator 165. In addition, visualindication may be provided by alignment of one or more visualindicators, such as ribs 161, 162, and 163 on first connection member 10and second connection member 70. In addition to providing a visualindication of a locked state, ribs 161, 162, and 163 may also providesupport for gripping the first connection member 10 and secondconnection member 70 for mating and unmating.

With reference to FIG. 20, the syringe adapter 2 is shown in a connectedor mated state with the patient connector 6 according to one aspect ofthe present invention. Interaction of protrusion 90 with notch 100 isshown in dashed lines. This interaction results in a positive lockwhereby mere rotation of either first 10 or second 70 connection membersrelative to the other is not sufficient to unmate the devices. Rather,application of some axial force (either pushing first 10 and second 70connection members together or pulling them apart) is required todisengage protrusion 90 from notch 100. Additionally, interaction offirst connection member 10 with second connection member 70 compressesthe compliant member 157 within second connection member 70. Thiscompression allows for needle 155 and fluid path 140 to become fluidlyconnected with fluid channel 130 of first connection member 10, andallows for passage of fluid between the syringe adapter 2 and patientconnector 6 and consequently between first and second containers and/oran intravenous patient line.

With reference to FIG. 21, the syringe adapter 2 is shown in a connectedor mated state with the vial adapter 4 according to one aspect of thepresent invention. The syringe adapter 2 is mated to the vial adapter 4to form a positive lock in the same manner described above with respectto the connection between the syringe adapter 2 and the patientconnector 6. The syringe adapter 2 and the vial adapter 4 provide thesame indicator 165 described above.

Also provided by one aspect of the present invention is a method offorming a connection for a medical device or connection apparatus. Themethod includes providing a first connection member 10 having a firstend 20 and a second end 25. The first end 20 includes a channel 30having a first, axial portion 35. The first end 20 may also include ashoulder 40 that at least partially defines a channel entry 50. Thechannel 30 of the first connection member 10 may be non-linear, andincludes a transverse portion 60 that is transverse relative to theaxial portion 35. The method further includes providing a secondconnection member 70 having a first end 80 and a second end 85. Thefirst end 80 of the second connection member 70 further includes aprotrusion 90, the protrusion configured to be received within thechannel 30 of the first connection member 10. The method furtherincludes mating the first connection member 10 with the secondconnection member 70, though those of skill will appreciate that thesecond connection member 70 can be mated with the first connectionmember 10 within the scope of the present invention.

In certain aspects, additional features of the first and secondconnection members 10, 70 may be included in the method of mating theconnection members. For example and without limitation, the transverseportion 60 of the channel 30 may include at its terminus one or morenotches 100, 110, and/or 120. In such an aspect, the mating stepincludes rotation of one or both of the connection members 10, 70relative to one another as the protrusion 90 proceeds through channel30. Further rotation brings protrusion 90 into engagement with one ormore notches 100, 110, and/or 120 to form a locked state betweenconnection members of the medical device or connection apparatus.Formation of a lock between connection members 10, 70 allows for fluidchannel 130 in first connection member 10 and fluid channel 140 insecond connection member 70 to form a fluid path through the medicaldevice or connection apparatus.

Turning to FIGS. 22-25, a second aspect of system for the closedtransfer of fluids is shown. The system includes a first connectionmember 2010 provided in connection with a vial adapter. The firstconnection member 2010 having a first end 2020 and a second end, whichin the figures includes vial attachment 2190. The first end 2020 may bea solid structure, and the second end may be any type of structure, forexample a vial attachment 2190. First connection member 2010 may beformed of any suitable material, such as, without limitation, plasticsand medical-grade polymers. Such polymers are available from DuPontunder the trade names Crastin®, Dekin®, Hytrel®, and Zytel®. Innon-limiting aspects in which the second end is a specific type ofadapter, first connection member 2010 may be formed of multiple suitablematerials, with first end 2020 formed of a plastic or medical-gradepolymer, or any suitable material.

With further reference to FIGS. 22-25, in a non-limiting aspect of thepresent invention, first connection member 2010 also includes at leastone channel 2030 that extends from a portion of the first end 2020distal from the second end to a portion of the first end 2020 proximalthe second end. The channel 2030 is utilized in the process of matingthe first connection member 2010 and a second connection member 2070,and may follow any useful path. In comparison to the non-limitingaspects shown in FIGS. 2-5, the aspect of the first connection member2010 shown in FIGS. 22-25 includes a less curved, more axially linearchannel.

The channel 2030 may have several discrete portions, including a channelentry 2050, an axial or substantially axial portion extending along thelength of the first end 2020 of first connection member 2010, and atransverse portion 2060 proximal to the second end that extendstransversely relative to the axial portion. First end 2020 of firstconnection member 2010, which includes channel entry 2050, furtherincludes a shoulder 2040 defining the channel entry 2050. Innon-limiting aspects, shoulder 2040 is not rounded, as shown in theaspect depicted in FIGS. 2-5. Rather, shoulder 2040 is more angular, butstill defines, and guides a protrusion of a second connection memberinto, channel entry 2050. The shoulder 2040 permits mating of the firstconnection member 2010 with a second connection member 2070 without theneed for the members to be in any predetermined orientation, increasingthe ease of achieving secure connections. The channel 2030 may alsodefine a notch 2100 to receive a portion of the second connection member2070.

Turning to FIGS. 23 and 24, shown are front and perspective views of thefirst connection member 2010 of a non-limiting aspect of the presentinvention mated to a second connection member 2070 that is embodied as asyringe adapter. Connection of first 2010 and second 2070 connectionmembers allows for formation of a fluid channel therebetween, andreconstitution, aspiration, and delivery of compounds. Elements of theconnection are substantially similar to the elements described in detailpreviously, except for the shape of channel 2030 and shoulder 2040 ofthe first connection member 2010, and include association of surfaces2026 and 2081 of first and second connection members 2010 and 2070,respectively. As with other aspects, arms 2191 of vial attachment 2190can encircle a vial and allow for needle 2195 to pierce vial fordelivery and/or withdrawal of liquids.

Turning to FIG. 25, a cross-sectional view of first connection member2010 mated to second connection member 2070 is shown. Second connectionmember 2070 has first and second ends, sidewalls 2160 defining a hollowportion 2170, and protrusion for mating with first connection member2010. In the non-limiting aspect shown in FIG. 25, second connectionmember 2070 includes as a second end a syringe adapter. Syringe adapterincludes luer lock 2121 for mating with any type of syringe. Those ofskill in the art will appreciate that luer locks can be used to mate thesyringe adapter with any type of syringe having a luer lock. Withreference to FIG. 25, the syringe adapter includes a male luer lock2121, which can be mated with any typical female luer lock (not shown).

Second connection member 2070 includes fluid channel 2140 and, innon-limiting aspects, includes seal or membrane apparatus 2150. The sealor membrane apparatus 2150 is configured to form a fluid-tight seal inthe fluid channel 2140. Seal or membrane apparatus 2150 can form afluid-tight seal in second connection member 2070 alone, or may form aseal for both fluid channel 2140 and a fluid channel 2130 of a firstconnection member 2010 when the second connection member 2070 is matedto first connection member 2010. Seal or membrane apparatus 2150 mayalso be a part of first connection member 2010.

In non-limiting aspects, seal or membrane apparatus 2150 may beself-healing, for example such that when a needle 2155 is included withsecond connection member 2070 in aspects in which second connectionmember 2070 includes a syringe adapter and first connection member 2010includes a vial attachment 2190, a user or healthcare practitionerreconstituting the compound in the vial actuates the syringe and theneedle pierces seal or membrane apparatus 2150. When the compound isreconstituted and the drug is to be withdrawn into the syringe,conclusion of that process can result in the syringe retracting throughseal or membrane apparatus 2150, restoring a fluid tight seal andpreventing exposure of the user or healthcare practitioner to thecompound.

In non-limiting aspects, seal or membrane apparatus 2150 may be also bea multi-component seal or membrane. For example, in the aspectillustrated in FIG. 25, seal 2150 is made up of three separatecomponents, 2151, 2152, and 2153. Portion of seal 2151 may be acompliant, self-healing membrane in which a needle 2155 may be embedded.The compliant nature of the seal allows for a fluid-tight seal to beformed between the chamber 2154 passing through the primary seal 2152and the chamber in which the majority of the needle 2155 is located.Third portion of seal 2153 is also self-healing, and maintains thechamber 2154 in isolation from the fluid channel 2140. A user orhealthcare practitioner reconstituting the compound in the vial actuatesthe syringe and the needle pierces seal 2153. When the compound isreconstituted and the drug is to be withdrawn into the syringe,conclusion of that process can result in the syringe retracting throughseal or membrane 2153 and into chamber 2154, restoring a fluid tightseal and preventing exposure of the user or healthcare practitioner tothe compound. Maintenance of the syringe between two fluid-tight seals2151, 2153 provides further protection for a user.

Seals or membranes suitable for use with the present invention in theaspect shown in FIG. 25 and described above, or with a singularself-healing seal or membrane, are well-known to those in the art andallow penetration by a point, i.e., needle, such that upon withdrawal ofthe point, the seal substantially reseals to preclude fluid passage.Suitable materials for the seals are well known in the art and should beselected based on the intended use for the device such asbiocompatibility, chemically inert, and compatible with any chemicalreagents or treatments contained therein, be FDA and/or OSHA approved,and suitable for use in CSTDs. Such seals may be formed out of naturalmaterials such as rubber, synthetic polymers, and/or silicone, such asroom temperature vulcanizing silicone.

Referring to FIGS. 26A-26E, further aspects of the protrusion 90 of thesecond connection member 70 are provided. Although the protrusion 90shown in FIGS. 1-25 is generally circular or semi-spherical, theprotrusion 90 may have any suitable shape that is configured to bereceived within the channel 30 of the first connection member 10. Inparticular, as shown in FIGS. 26A-26E, the protrusion 90 may becircle-shaped, oblong-shaped, diamond-shaped, square-shaped, orrectangle-shaped. Each of these shapes may be utilized with the channel30 and notch 100 shown in FIG. 2 or the channel 30 and notches 110, 120shown in FIGS. 7A and 7B and where the protrusion 90 has a clearancearrangement into the notches 100, 110, 120 or a frictional engagementinto the notches 100, 110, 120. The square-shaped and rectangle-shapedprotrusions 90 may be particularly suited for the clearance arrangementsto ensure a secure engagement within the notches 100, 110, 120.

While the present invention is described with reference to severaldistinct aspects of a connection apparatus for a CSTD and methods of usethereof, those skilled in the art may make modifications and alterationswithout departing from the scope and spirit of the invention.Accordingly, the above detailed description is intended to beillustrative rather than restrictive.

What is claimed is:
 1. A connection apparatus for a medical devicecomprising: a first connection member having a first end and a secondend, the first connection member defining at least one channel adjacentthe first end, the at least one channel having a first portion extendingin an axial direction, the at least one channel having a shoulderadjacent to the first end of the first connection member that defines achannel entry, the at least one channel having a second portionextending in a transverse direction relative to the axial direction anddefining a terminus; and a second connection member having a first endand a second end, the first end defining an interior cavity having atleast one protrusion therein, wherein when the at least one protrusionof the second connection member enters the at least one channel of thefirst connection member, axial movement of the second connection membertowards the first connection member causes engagement of the at leastone protrusion with the first connection member and at least one of thefirst and second connection members to rotate relative to the otherconnection member to enter a locked state where the at least oneprotrusion reaches the terminus of the second portion of the at leastone channel, wherein the shoulder is configured to guide the at leastone protrusion of the second connection member into the channel entryregardless of the orientation of the at least one protrusion relative tothe channel entry, and wherein the connection apparatus furthercomprises a visual indicator of the locked state between the firstconnection member and the second connection member.
 2. The connectionapparatus of claim 1, wherein the channel entry is wider than the firstportion of the at least one channel and the second portion of the atleast one channel.
 3. The connection apparatus of claim 1, wherein thesecond portion of the at least one channel comprises a notch extendingin the axial direction.
 4. The connection apparatus of claim 3, whereinthe notch extends towards the first end of the first connection member.5. The connection apparatus of claim 3, wherein the notch extendstowards the second end of the first connection member relative to thesecond portion of the at least one channel.
 6. The connection apparatusof claim 3, wherein the at least one protrusion forms a positive lockwith the notch to removably secure the first connection member to thesecond connection member when the first and second connection membersare in the locked state.
 7. The connection apparatus of claim 1, whereinthe second portion of the at least one channel comprises a substantiallyaxial notch extending distally and a substantially axial notch extendingproximally relative to the first end of the first connection member. 8.The connection apparatus of claim 1, wherein the first and secondconnection members further comprise fluid channels therethrough suchthat when the first connection member and second connection member aremated, the fluid channels form a fluid path.
 9. The connection apparatusof claim 8, wherein at least one of the first connection member andsecond connection member further comprises a self-healing membrane inthe respective fluid channel and wherein when the first connectionmember is mated with the second connection member, the self-healingmembrane forms a fluid-tight seal.
 10. The connection apparatus of claim1, wherein the first and second connection members each comprise a flatportion and a rounded portion, the visual indicator comprising alignmentof the flat portion of the first connection member with the flat portionof the second connection member and the alignment of the round portionof the first connection member with the round portion of the secondconnection member.
 11. The connection apparatus of claim 1, wherein theindicator is a tactile indicator, and wherein the interaction of the atleast one protrusion with a notch provides tactile indication of thelocked state.
 12. The connection apparatus of claim 1, wherein the firstend of the second connection member comprises sidewalls enclosing ahollow portion, the sidewalls extending axially away from the second endof the second connection member, and wherein the sidewalls include theat least one protrusion, the at least one protrusion extending inward.13. The connection apparatus of claim 1, wherein one of the firstconnection member and second connection member is provided on a syringeadapter and the other connection member is provided on at least one of avial adapter and a patient connector.
 14. The connection apparatus ofclaim 1, wherein the shoulder is rounded and the first portion of the atleast one channel defines a non-linear path.